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EC number: 940-272-6 | CAS number: 2097734-13-7
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
One repeated dose toxicity study according to OECD guideline 422 was conducted to obtain information on possible effects of the test item DiPT on general toxicity, reproduction and/or development .
No influence was noted on the fertility and the reproductive parameters of the parental generation (F0-Generation) with respect to fertility, pre-coital time, gestation length, gestation index, number of stillbirths, birth and live birth index and the preand post-implantation loss for any of the examined dose levels.
The NOAEL for adverse effects on fertility and reproduction parameters is above the highest administered dose 1000 mg test item/kg b.w./day, p.o..
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- based on test type
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
- Species:
- rat
- Strain:
- other: CD/Crl:CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH
Sandhofer Weg 7
97633 Sulzfeld
Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Males (MS, RC)+ Females (MS, RC): 71 days
- Weight at study initiation:
Males (MS): 345.9 - 390.5 g
Males (RC): 350.6 - 372.8 g
Females (MS): 219.7 - 261.1 g
Females (RC): 229.5 - 255.9 g
- Housing:
With the exception of the mating period (see Section 3.9 'Mating procedure'), the
males and females (F0-Generation) were kept singly in MAKROLON cages (type III
plus) with a basal surface of approx. 39 cm x 23 cm and a height of approx.
18 cm.
- Diet : ad libitum
- Water: ad libitum
- Acclimation period: 6 days
DETAILS OF FOOD AND WATER QUALITY:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 55% ± 15%
- Photoperiod (hrs dark / hrs light): The rooms were alternately lit (about 150 lux at approx. 1.5 m room height) and
darkened for periods of 12 hours.
IN-LIFE DATES:
First administration March 18, 2015
End of the in-life period Males: MS: April 16, 2015
RC: May 12, 2015
Females: MS: May 02, 2015
RC: May 12, 2015- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
VEHICLE
- Amount of vehicle (if gavage): 2 mL/kg b.w./day- Details on mating procedure:
- - M/F ratio per cage: 1 male and 1 female animal were placed in one cage during the dark period.
- Length of cohabitation: until pregnancy had occured
- Proof of pregnancy: vaginal plug / sperm in vaginal smear referred to as day 0 of pregnancy
- After 14 days of unsuccessful pairing replacement of first male by another male with proven fertility.
- After successful mating each pregnant female was caged (how): single - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Method: HPLC-UV Detection
- Duration of treatment / exposure:
- Main study: The male rats were dosed from test day one until, and including, test day 29 and were sacrificed on test day 30. The female rats were dosed between test day one and test day 40 (first sacrificed female on test day 41) or test day 45 (last sacrificed female on test day 46).
Recovery: The maöes and females were dosed from test day one until, and including, test day 40 and were sacrificed on test day 56. - Frequency of treatment:
- Once daily
- Remarks:
- Doses / Concentrations:
Group 2: 100 mg/kg b.w./day
Basis:
analytical conc. - Remarks:
- Doses / Concentrations:
Group 3: 300 mg/kg b.w./day
Basis:
analytical conc. - Remarks:
- Doses / Concentrations:
Group 4: 1000 mg/kg b.w./day
Basis:
analytical conc. - No. of animals per sex per dose:
- Main study: 12 animals/sex/dose
Recovery: 5 animals/sex/dose - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: The dose levels were selected by the Sponsor based on available toxicological data and a 14-day dose range finding study
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: at leat once daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: at least once daily; individual animals were observed before and after dosing at each time of dosing
BODY WEIGHT: Yes
- Time schedule for examinations:Males and females were weighed on the first day of dosing, weekly thereafter and at termination. During gestation, females were weighed on days 0, 7, 14 and 20 and within 24 hours of parturition (day 1 post-partum) and day 4 post-partum.
FOOD CONSUMPTION AND COMPOUND INTAKE:
- Food consumption for individual animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
WATER CONSUMPTION AND COMPOUND INTAKE: Yes
- Time schedule for examinations: daily by visual appraisal - Sperm parameters (parental animals):
- Parameters examined in [group 1 and 4] male parental generations:
Detailed histopathological examination was performed on one testicle and one epididymis with special emphasis of the qualitative stages of spermatogenesis and histopathology of interstitial testicular structure of the selected male animals of the main study groups 1 and 4. - Litter observations:
PARAMETERS EXAMINED
The following parameters were examined in F1 offspring:
number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain, physical or behavioural abnormalities
GROSS EXAMINATION OF DEAD PUPS:
yes- Postmortem examinations (parental animals):
- SACRIFICE
- Main study Male animals: All surviving animals were sacrified on test day 30.
- Main study Maternal animals: All surviving animals were sacrified 24 days after the last day of the mating period.
-Recovery study:All male and female animals allocated to the recovery period were sacrificed on test day 56.
GROSS NECROPSY
All superficial tissues were examined visually and by palpation and the cranial roof removed to allow observation of the brain, pituitary gland and cranial nerves. After ventral midline incision and skin reflection all subcutaneous tissues were examined. The condition of the thoracic viscera was noted with due attention to the thymus, lymph nodes and heart. The abdominal viscera were examined before and after removal. The urinary bladder was examined externally and by palpation. The gastro-intestinal tract was examined as a whole and the stomach and caecum were incised and examined. The lungs were removed and all pleural surfaces were examined under suitable illumination. The liver and the kidneys were examined. Any abnormalities in the appearance and size of the
gonads, adrenals, uterus.
HISTOPATHOLOGY / ORGAN WEIGHTS
The following tissues were prepared for microscopic examination:
Epididymis (2)
Gross lesions
Mammary gland (females only)
Ovary (2)
Prostate
Seminal vesicle
Testicle (2)
Uterus (incl. cervix and oviducts)
Vagina
Adrenal gland (2)
Bone marrow (os femoris)
Brain (cerebrum, cerebellum, brain stem)
Heart (left and right ventricle, septum)
Intestine, small (duodenum, jejunum, ileum,
incl. Peyer's patches, Swiss roll method)
Intestine, large (colon, rectum)
Kidney and ureter (2)
Liver
Lungs (with mainstem bronchi and
bronchioles), preserved by inflation with
fixative and then immersion
Lymph node (1, cervical)
Lymph node (1, mesenteric)
Nerve (sciatic)
Spinal cord (3 sections)
Spleen
Stomach
Thyroid (incl. parathyroid)
Thymus
Tissue masses or tumours (incl.
regional lymph nodes)
Trachea (incl. larynx)
Urinary bladder
The weights of the following organs were determined:
Adrenal gland (2)
Brain
Heart
Kidney (2)
Liver
Spleen
Thymus - Postmortem examinations (offspring):
GROSS NECROPSY
Dead pups and pups sacrificed at day 4 post-partum were carefully examined externally
for gross abnormalities.- Statistics:
- Statistical analyses of the parametrical values, captured or calculated by Provantis (i.e. clinical signs, parental body weight, body weight gain,
food consumption,haematological and biochemical parameters), were done by Provantis. - Reproductive indices:
- The following indices were calculated for each group:
Male fertility Index [%]
Female fertility Index [%]
Gestation Index [%]
Birth Index [%]
Live Birth Index [%]
Survival Index [%]
Pre-implantation loss [%]
Post-implantation loss [%] - Clinical signs:
- effects observed, non-treatment-related
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, non-treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, non-treatment-related
- Food efficiency:
- effects observed, non-treatment-related
- Water consumption and compound intake (if drinking water study):
- effects observed, non-treatment-related
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, non-treatment-related
- Clinical biochemistry findings:
- effects observed, non-treatment-related
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Histopathological findings: neoplastic:
- effects observed, non-treatment-related
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No test item-related influence was noted on the
mean number of corpora lutea per dam, the mean
number of implantation sites per dam, the mean
number of pups born (alive and dead) per dam,
the mean number live born pups per dam and the
reproductive indices (birth index, live birth index,
pre- and post implantation loss). - Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects for systemic toxicity and on fertility and reproductive parameters were recorded until the highest dose of 1000 mg/kg bw.
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- not examined
- Clinical signs:
- not examined
- Mortality / viability:
- mortality observed, non-treatment-related
- Body weight and weight changes:
- effects observed, non-treatment-related
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- effects observed, non-treatment-related
- Histopathological findings:
- not examined
- Behaviour (functional findings):
- not examined
- Developmental immunotoxicity:
- not examined
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- > 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects on the development of the pups were recorded.
- Key result
- Reproductive effects observed:
- no
- Conclusions:
- The aim of the study was to obtain information on possible effects of the test item
on general toxicity, reproduction and/or development according to OECD guideline
422. The test item Di-(iso)-pentyl terephthalate (DPT) was administered orally to
rats at dose levels of 100, 300 or 1000 mg test item/kg b.w./day.
General toxicity
No premature death, no test item-related signs of clinical toxicity and no test itemrelated
influence on the neurological function were noted for animals of the main
and the recovery study.
Body weight, food consumption and the haematological and biochemical parameters
were not influenced by the test item.
Necropsy revealed no test item related changes during the macroscopic and microscopic
examinations and on the weights of the examined organs.
Reproductive toxicity
No influence was noted on the fertility and the reproductive parameters of the parental
generation (F0-Generation) with respect to fertility, pre-coital time, gestation
length, gestation index, number of stillbirths, birth and live birth index and the preand
post-implantation loss for any of the examined dose levels.
No adverse effects were noted on the development of the pups (F1-Generation)
with respect to survival index, body weight, and gross abnormalities.
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 200 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Description of key information
One repeated dose toxicity study according to OECD guideline 422 was conducted to obtain information on possible effects of the test item DiPT on general toxicity, reproduction and/or development .
No adverse effects were noted on the development of the pups (F1-Generation) with respect to survival index, body weight, and gross abnormalities. The NOAEL for adverse effects on the development of the pups
is above the highest administered dose 1000 mg test item/kg b.w./day, p.o..
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 10 000 mg/m³
- Study duration:
- subacute
- Species:
- other: rat and rabbit
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
No classification for reproductive toxicity is indicated according to the classification, labeling, and packaging (CLP) regulation (EC) No 1272/2008.
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